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 The leading web portal for pharmacy resources, news, education and careers November 20, 2017
Pharmacy Choice - Pharmaceutical News - FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's DS-8201 for HER2-Positive Metastatic Breast Cancer - November 20, 2017

Pharmacy News Article

 9/13/17 - FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's DS-8201 for HER2-Positive Metastatic Breast Cancer

By a News Reporter-Staff News Editor at Biotech Week Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1) (see also Pharmaceutical Companies).

Breakthrough Therapy designation is designed to expedite the development and review of medicines that may demonstrate substantial benefit over currently available treatments in order to ensure that patients with serious diseases have access to new treatments as soon as possible. Currently, there is no FDA-approved therapy for patients with HER2-positive metastatic breast cancer with disease progression following treatment with other HER2-targeting agents trastuzumab, pertuzumab and T-DM1.

"The Breakthrough Therapy designation for DS-8201 in HER2-positive metastatic breast cancer acknowledges the unmet medical need these patients face when currently approved treatments no longer control their disease," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We remain committed to rapidly progressing the development of DS-8201 and look forward to working closely with the FDA to potentially bring this new treatment option to patients with metastatic breast cancer as quickly as possible."

The Breakthrough Therapy designation was granted based on the results of the ongoing phase 1 study assessing the safety, tolerability and preliminary efficacy of DS-8201. In the phase 1 study, no dose limiting toxicities were observed, and the maximum tolerated dose was not reached. Preliminary results of DS-8201 from a subgroup analysis of HER2-expressing metastatic breast cancer pre-treated with trastuzumab, pertuzumab and T-DM1 were recently presented at the 2017 American Society of Clinical Oncology (ASCO) annual meeting.1

Keywords for this news article include: Antineoplastic Monoclonal Antibodies, Biotechnology, Pharmaceutical Companies, Oncology, Pertuzumab, Trastuzumab, Breast Cancer, Immunotherapy, Women's Health, HER2 Inhibitors, Medical Devices, Disease Attributes, Disease Progression, Drugs and Therapies, Pathologic Processes, Tyrosine Kinase Inhibitors.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC



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